đź“Š Evidence-Based Reference
Microthermx-100 Microwave Ablation System and Accessories
Bsd Medical Systems
Summary: The MicroThermX-100 is a microwave ablation system used primarily for tumor ablation. Key evidence highlights its efficacy in treating hepatocellular carcinoma with a focus on safety and precision.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K081042 ↗
Decision Date ?
September 3, 2008
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The MicroThermX-100 Microwave Ablation System by BSD Medical Systems was cleared by the FDA via the 510(k) pathway on September 3, 2008. It is classified as a Class 2 medical device.
What It Is
The MicroThermX-100 is a microwave ablation system designed for the thermal ablation of tumors. It uses microwave energy to generate heat, causing coagulative necrosis in targeted tissues, and is intended for use in minimally invasive procedures.
FDA-Cleared Indications
- Thermal ablation of tumors using microwave energy.
- Use with compatible microwave ablation accessories for coagulative necrosis of targeted tissue.
- Use in percutaneous, laparoscopic, or open surgical procedures, according to the cleared system labeling.
Clinical Applications
- Percutaneous microwave ablation of selected localized tumors under imaging guidance.
- Laparoscopic microwave ablation of selected tumors.
- Open surgical microwave ablation of selected tumors.
- Microwave ablation of hepatocellular carcinoma when the patient, tumor, and treatment plan meet the system labeling and clinical requirements.
Reported off-label uses
- Microwave ablation of tumors in organs or clinical situations not specifically covered by the device labeling may be reported in clinical practice or literature, but this should be considered off-label and evaluated by the treating specialist.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, retrospective analyses, and case series, published between 2022 and 2024. These studies evaluate the efficacy and safety of microwave ablation systems, including the MicroThermX-100.
Reported Outcomes
Published studies report that the MicroThermX-100 is effective in achieving significant tumor ablation with precise control over ablation zones. The system has demonstrated comparable efficacy to other high-power microwave systems in treating liver tumors, with favorable outcomes in terms of tumor size reduction and local control.
Safety Profile
Reported complications include minor thermal injuries to adjacent tissues and transient post-procedural pain. Overall, the safety profile is consistent with other microwave ablation systems, with no significant increase in adverse events reported.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to compare the MicroThermX-100 directly with other ablation technologies in larger, randomized trials.
Practical Considerations
- The system requires a compatible microwave ablation antenna and generator; accessory availability, antenna length, active-tip configuration, and maximum treatment settings depend on the cleared system configuration.
- Ablation is typically planned with ultrasound, CT, or another appropriate imaging modality to target the lesion and monitor the treatment zone.
- The procedure may use local anesthesia with moderate sedation or general anesthesia, depending on the tumor location, access route, and whether the procedure is percutaneous, laparoscopic, or open.
- MRI safety and conditional-use requirements should be confirmed for the generator, antenna, cables, and other accessories before any MRI examination; do not assume the complete system is MRI safe.
- Contraindications and precautions depend on the tumor, access route, nearby organs or vessels, bleeding risk, infection risk, implanted devices, and the current manufacturer labeling.
Frequently Asked Questions
What are the clinical indications for MicroThermX-100?
The MicroThermX-100 is indicated for the ablation of soft tissue tumors, including hepatocellular carcinoma, in minimally invasive procedures.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor size reduction and local control, with outcomes comparable to other high-power microwave systems.
What complications have been reported?
Safety data indicate minor thermal injuries and transient pain as the most common complications, with no significant increase in adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.